Clinical Program & Manufacturing Resources
OIRM is currently working to develop a robust portfolio of resources to augment Ontario’s clinical and manufacturing capacity.
Clinical Translation Initiative Workshops
The Clinical Translation Initiative Workshop series has been developed to focus on the translation of research studies from the lab into the clinic. Workshops are held 2-3 times per year, each focusing on a different aspect of this process. Participation is open to OIRM scientists, clinicians, and trainees. Details of upcoming workshops are posted on the Workshops, Courses and Events page and communicated through the OIRM Newsletter.
Past workshop topics have included: cell manufacturing for clinical translation, clinical trial design, reimbursement modeling, and regulatory considerations.
Reading/video Resources
- A short guide to cell therapy manufacturing, part 1: Process and scalability – published in Expression (Dec 2017)
- A short guide to cell therapy manufacturing, part 2: Risk and regulation – published in Expression (Feb 2018)
- Bench to Bedside for Biotherapeutics (B3) video series
- How can you predict if your discovery is translatable? (40 min)
- How do I take my research and make it into a marketable product? (35 min)
- How do I communicate where I’m at in the clinical translation continuum? (20 min)
- Making the goods: Cleanliness, orderliness, scaling and other considerations (35 min)
- Designing pre-clinical studies to support in-human trials, part 1 (20 min)
- Designing pre-clinical studies to support in-human trials, part 2 (21 min)
- What’s the process of designing and applying for a clinical trial? (45 min)
- Understanding clinical adoption: How a therapy is reimbursed (30 min)
- Health Canada Guidelines for Cell Therapies